FDA.reportPublic FDA data

Burn Relief Spray

Manufacturer
Foodhold USA
Effective date
2025-10-27
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:41:01

Label at a glance#

ProductLidocaine
Active ingredientLIDOCAINE
Label structure9 sections

Indications and uses

for temporary relief of pain and itching associated with: sunburn minor burns minor cuts insect bites scrapes minor skin irritations

Dosage and administration

shake can well for adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily for children under 2 years of age: consult a doctor to apply to face spray in palm of hand and gently apply

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 0.5%

Purpose

OTC - PURPOSE SECTION

External analgesic

Uses

INDICATIONS & USAGE SECTION

for temporary relief of pain and itching associated with:

  • sunburn
  • minor burns
  • minor cuts
  • insect bites
  • scrapes
  • minor skin irritations

Warnings

WARNINGS SECTION

For external use only.

Flammable:

SAFE HANDLING WARNING SECTION

Use only as directed. Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF. Intentional misuse by delibrately concentrating and inhaling the contents can be harmul or fatal.

Do not use

OTC - DO NOT USE SECTION

in large quantities, particularly over raw surfaces or blistered areas.

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes
  • ask a doctor before using on children under 2 years of age

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition gets worse
  • symptoms last more than 7 days or clear up and occur again in a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake can well
  • for adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • for children under 2 years of age: consult a doctor
  • to apply to face spray in palm of hand and gently apply

Other information

OTHER SAFETY INFORMATION

store between 20º to 25ºC (68º to 77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, butane, carbomer, diazolidinyl urea, disodium cocoamphodipropionate, disodium EDTA, glycerine, methylparaben, propane, propylene glycol, propylparaben, simethicone, tocopheryl acetate (vitamin E acetate), triethanolamine, water

Questions?

OTC - QUESTIONS SECTION

Call 1-866-964-0939

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CareOne

Burn Relief Spray

Lidocaine

Relieves Pain and Itching from Sunburn, Minor Burns and Insect Bites

Cools, Moisturizes and Soothes Sunburned Skin

NET WT 4.5 OZ (127g)

Burn Relief SprayBurn Relief Spray

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1442274lidocaine 0.5 % Topical SprayPSN9
1442274lidocaine 5 MG/ML Topical SpraySCD9
1442274lidocaine 0.5 % Topical SpraySY9

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41520-162-452024-01-17C16284748780-1c7ccaba7-0e97-fd44-e053-dadaa90aa01bBurn Relief Spray
41520-162-452024-01-17C16284748780-1c7ccaba7-0e97-fd44-e053-dadaa90aa01bBurn Relief Spray
41520-162-452021-07-23C16284748780-1c7ccaba7-0e97-fd44-e053-dadaa90aa01bBurn Relief Spray
41520-162-452021-07-23C16284748780-1c7ccaba7-0e97-fd44-e053-dadaa90aa01bBurn Relief Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-162-45Lidocaine127 g in 1 CANAEROSOL, SPRAY1279

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-16241520-162-45

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTANE6LV4FOR43RIACT
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
ALOE VERA LEAFZY81Z83H0XIACT
DISODIUM COCOAMPHODIPROPIONATE6K8PRP397MIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
PROPANET75W9911L6IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82024-12-17full-release2026-06-01 00:44:53

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidocaineBURN RELIEFFoodhold USAb25dc0df-02d0-41ac-b36c-2c04baa77ef22025-10-27WarningsExact identifier
ndc (package): 41520-162-45
ndc (product): 41520-162
ndc11 (package): 41520016245
spl id: 422a7da3-a992-d61d-e063-6294a90a3789
spl set id: b25dc0df-02d0-41ac-b36c-2c04baa77ef2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.